Massachusetts General Hospital
This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).
This is a prospective, placebo-controlled, randomized, single-blinded, multi-center, phase II study of the mutant IDH1 inhibitor, ivosidenib, compared to placebo in participants with AML after HCT. This study is examining whether or not ivosidenib is beneficial as an agent to prevent the relapse of IDH1-mutated acute myeloid leukemia after hematopoietic stem cell transplantation. The U.S. Food and Drug Administration (FDA) has not approved ivosidenib for this indication following HCT but it has been approved for other uses. The research study procedures include screening for eligibility and s…
Inclusion Criteria: * Pathologically confirmed diagnosis of IDH1(R132)-mutant acute myeloid leukemia (AML). IDH1 mutations could have been detected by any mutational technique at any prior point including at diagnosis or remission. * Between the ages of 18 and 75 years * Will undergo allogeneic hematopoietic stem cell transplantation (HSCT) for their malignancy. Conditioning may be either conventional myeloablative (MAC) or reduced intensity conditioning (RIC). There will be no restrictions on type of graft source. * ECOG performance status ≤ 2 * Participants must have normal organ and marrow…
Ivosidenib tablets are supplied as 50 mg, 200 mg, and 250 mg strengths, to be taken orally.
Placebo tablets are taken orally.